EP1455641B1 - Procede et dispositif de suivi de la concentration d'un analyte par detection optique - Google Patents

Procede et dispositif de suivi de la concentration d'un analyte par detection optique Download PDF

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Publication number
EP1455641B1
EP1455641B1 EP02791814A EP02791814A EP1455641B1 EP 1455641 B1 EP1455641 B1 EP 1455641B1 EP 02791814 A EP02791814 A EP 02791814A EP 02791814 A EP02791814 A EP 02791814A EP 1455641 B1 EP1455641 B1 EP 1455641B1
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EP
European Patent Office
Prior art keywords
areas
light
compounds
tissue
detection means
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Expired - Lifetime
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EP02791814A
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German (de)
English (en)
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EP1455641A1 (fr
Inventor
Holger Dirac
Kasper Oktavio Schweitz
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BMC Ventures AS
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Danfoss AS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light

Definitions

  • This invention relates to biological sensors, more specifically to implantable sensors for optically detecting compounds such as glucose, in a living creature, for example, in the human or animal body. More specifically, but not exclusively, this invention relates to biological sensors for the detection of glucose in blood or tissue of a diabetic patient.
  • Diabetic patients can improve their life quality and life expectancy by maintaining their blood glucose concentration close to the natural level of a healthy person. To achieve this natural concentration, diabetic patients must frequently measure their glucose concentration, and adjust their insulin dosing in accordance with the measured concentration.
  • a blood sample is obtained for measurement of blood glucose concentration, and there are a number of different glucose test kits on the market based on measurement from a blood sample. The disadvantage of these test kits is the need to take a blood sample which must be collected from a suitable place in the body.
  • Biological sensors in the form of implantable devices are also known in the art and include electrochemical devices and optical devices based on the creation of an electrical or optical signal by the consumption of the compound detected by the analysis.
  • An example is to be found in US 6,011,984 , which discloses methods utilising an amplification component.
  • the sensitivity and the responsivity of such devices are influenced by the formation of a bio film, for example, by fibrous encapsulation of the device which reduces the transport rate of the compound to the sensor.
  • other mechanisms which cause deterioration of sensor performance of implanted devices may also be present, for example, membrane de-lamination and degradation, enzyme degradation and electrode passivation.
  • WO00/33065 discloses an implantable glucose sensor comprising a photodetector unit, for detecting light from an external light source, and a signal processing unit for evaluating glucose concentrations. Data may be transmitted to a drug delivery pump.
  • a device for in-vivo measurements of concentrations of substances in a body fluid comprising a light source, a light detector and a light transmitter/reflector to be implanted within the body.
  • the light transmitter may comprise two light reflecting surfaces at different levels beneath the skin, one forming a measurement surface and the other forming a reference surface.
  • the present invention provides a device for implantation beneath the skin of a living creature, the device having outer surfaces of biocompatible material and comprising the features as defined in claim 1.
  • the difference between the said distances allows a differential analysis to take place so that the effects of skin in the results can be reduced or avoided.
  • the differential analysis may be a simple formation of a difference in signals or may be a complex computer correlation.
  • the analysis may be performed within the device or externally.
  • Such a device can be used to provide an alternative way to overcome the discomfort and inconvenience for diabetic patients, by providing (once the initial implantation is finished) a non-invasive measurement method for glucose concentration.
  • the implanted detector may be divided into areas at different levels. By this means, the distance travelled by the light through the compound of interest in the body tissues, and thus the interaction of light with the compound, varies from area to area.
  • the spacing between the different levels may, for example, be between 0.5 and 5 millimetres, for example, between 0.5 and 3 millimetres, for example between 1 and 2.5 millimetres.
  • the number of areas within a group may, for example, be between 2 and 30, for example, between 5 and 25, for example, between 10 and 20.
  • the device may include means to provide a differential analysis of signals arising from the said difference in distances. Instead, a differential analysis may be performed on the data in an external apparatus to which the device transmits data.
  • Heating means and/or cooling means may be provided to act on the body region surrounding the device.
  • the areas may be provided within wells to reduce the effects of stray light.
  • the areas may be covered by optical filter means to prevent light of wavelengths other than those of interest from reaching the areas.
  • each group of areas forms a common level
  • the common levels have a predetermined spacing from each other to provide the said difference in distance over which light interacts with compounds and tissue.
  • the first group of areas is formed at a base level of the device and the second group of areas is formed by projections from the said base level to a top level.
  • the device further includes a spacer covering one of said at least one areas or groups so that compounds and tissue are unable to fill the volume of the spacer, the spacer providing the difference in distance over which light interacts with compounds and tissue.
  • the spacer can be formed by a sealed volume above some of the areas so that light reaching those areas experiences less interaction with the compound and tissues than light reaching uncovered reflecting areas.
  • At least one substantially flat area constituting a third area or group of areas may be provided and form a common level between the base level and the top level.
  • At least a part of one of said areas may be formed by a permeable membrane.
  • the said membrane may be permeable to glucose.
  • the invention also provides a method for optically detecting the content of a compound in the body of a living creature, the method comprising:
  • the analysis of the detected signals is a differential analysis or is based ou an average of signals.
  • the compound may be glucose.
  • the measuring principle used in this invention is not, however, limited to implanted devices in diabetic patients for measuring glucose concentration, but can be used in many other applications.
  • the basic principle can be used for measuring compounds in locations which are difficult to access, and where the physical and chemical conditions vary over time. Measurement can be made of glucose concentration in a bioreactor, glucose in fruit juice etc.
  • the invention also provides a device for implantation beneath the skin of a living creature, the device having outer surfaces of biocompatible material and comprising:
  • optical methods based on the interaction of light with compounds and body tissues are utilised.
  • the optical methods in their general aspects correspond to those described in the literature, for example, using Beer-Lambert law and/or radiative transport theory and will not therefore be described further here.
  • light from a light source is incident on an implanted detector, the light is detected by a detection device in the implanted detector, and a signal is transmitted to a receiving device for analysis.
  • the characteristics of the detected light depend on the interaction with the compounds encountered on the way from the light source to the detector.
  • the implanted detector is divided into areas at different levels, so that the distance for the light through the compounds, - and thus the interaction with light, varies from area to area.
  • a differential analysis is performed on signals produced by the detector.
  • an implanted device 1 is placed underneath the skin 2 so that the compound to be measured is contained between the skin and the implanted device.
  • An optical device 3, containing a light source 30 and a lens system 5, is placed external to the skin above the implanted device, and a signal for the detected light is transferred from the implanted device to a receiver 6.
  • the light intensity emitted from the light source is preferably approximately constant over the whole of the implanted device. It is thereby ensured that variations in the detected light are due only to absorption in the path from light source to detector and not due to variations in emitted light intensity.
  • the light source is, for example, a light source of a broad continuous spectrum, for example a thermal white light source, depending on the compound to be measured.
  • the wavelength should be well represented in the near infrared spectrum, more specifically between 1000 and 2500 nm.
  • the light source is in this case therefore, for example, an LED, one or more laser diodes or an LED array producing wavelengths in this range.
  • a monochromator can be used with a white light source to select light within a desired wavelength range and directed onto the implanted device.
  • Wavelength specific light detection can also be obtained by covering the detectors with a film, transparent for only a specific wavelength or wavelength range. In this way is it possible to detect within a range of wavelengths simply by having a light source with a range of wavelengths and a number of detectors with different films. The film covering each detector also prevents detection of background light, as this not will pass through the film. Alternatively the detection within a range of wavelengths can be carried out by having more than one light source, and successively directing light of different wavelengths on the implanted device.
  • Fig. 1 shows a cooling/heating device 7, such as a Pelletier element, formed as a ring around the light emitting area.
  • a cooling/heating device 7 such as a Pelletier element, formed as a ring around the light emitting area.
  • the actual temperature can be recorded by a thermo element or the like, placed in the device 3.
  • the implanted device 1 contains a number of photo detectors 8, which by wires 17 are connected to an electronic circuit device 18.
  • the electronic circuit device can be operated by power and data transmission without the use of connecting wires to the outside.
  • Such power transmission can be implemented by the use of a so-called inductive link, which is basically a coreless transformer.
  • Transmission of data from the electronic circuit device to the external receiver can take place, for example, by varying the load seen by the secondary of the transformer located in the implanted device (for example, the resistance change of a photo conductivity cell), or for example, by measuring the change of resonance frequency of a series resonant circuit (for example, the change of capacitance due to the photo current in a photo diode).
  • the implanted device shown here consists of a number of detectors 8, contained in a polymeric or elastomeric matrix with biocompatible surfaces.
  • the shape of the detector is made step-like to provide two levels of detection areas, base level 9 and extended level 10. In this way the detected light varies depending on which level the light is detected in, and-the variation is dependent on the interaction of light with compounds and components in the volume between the two levels, henceforth called the measurement volume 11.
  • the implanted device can, for example, have a step-like shape in one direction, as indicated by an arrow in fig. 3 , or a step-like shape in two directions as indicated by two arrows in fig, 4 . Having more than one detector at each level increases the sensitivity of the analysis, as the signals from each level can then be averaged.
  • each detector is shown placed in a detection well 12 so that only parallel light is detected. This has the effect that only the emitted and directly transmitted light is detected and not light from another light source, such as background light.
  • the membrane is sufficiently transparent at the appropriate wavelengths employed for the measurement (if placed on top of the measurement volume), and is permeable to the compound to be measured, for example glucose, but prevents other molecules larger than the compound to be measured from entering the measurement volume.
  • the membrane can be placed above the measurement volumes, that is, between measurement volumes and the light source and detector, and/or to the sides of the measurement volumes. Placing the membrane to the side of the measurement volume enables a long optical path length and at the same time a relatively short response time of the device with respect to changes in the concentration in the surrounding tissue and liquid.
  • the measurement volume can be filled with liquid or with a solid matrix permeable to a compound to be analysed.
  • the detected signal of the device is calibrated to a known concentration of the compound to be analysed, either one time for all or preferably from time to time. Measuring the concentration in a sample, taken at the same time as the optical measurement, can be used to achieve this calibration.
  • the device however can be made self-calibrating, if two measurement volumes contain a known concentration of compound.
  • a part of the device is covered with a diffusion proof lid 14 instead of with a membrane.
  • bio film on the implanted device will have less effect than is the case for electrochemical devices or other devices in which the compound to be measured is consumed in the measurement process. As long as the bio film is sufficiently transparent at the optical wavelengths employed, the bio film will have very little effect on the measurement. In the case where a membrane is used, as described above, the bio film may influence the response time with respect to changes in the concentration in the surrounding tissue and liquid, but is will still have little effect on the measurement itself.
  • the two levels of detection areas can be increased to three or more different levels.
  • the dynamic range of the sensor can be increased, as the analysis of the detected signal then discloses three or more levels corresponding to 2 or more interaction volume optical path lengths.
  • more information is made available for data analysis to establish compound concentrations using, for example, chemometric, multivariant data analysis approaches. More levels also facilitate consistency and quality control of data.
  • the implanted device is shown made as a laminated structure, where a base plate 19 contains the detectors, the wiring and an electronic circuit device.
  • the top part 20 is laminated on the base plate, where after the base plate and the top part together forms the implantable device.
  • two spaces 21 and 22 are made, simply by removing some material from the top part 20.
  • the two spaces form two areas so that the device is able to detect light from two areas.
  • the space 21 is created on the surface of the top part which faces away from the base plate so that compounds and tissue have access to the space when the device is implanted.
  • the space 22 however is formed on the surface of the top part which faces towards the base plate so that compounds and tissue have no access to the space 22 when the device is implanted, as the space 22 is closed. This is indicated in figure 10 , showing a section through X-X of the top part of figure 9 .
  • space 21 and space 22 The detecting area underneath space 21 and space 22 is formed on the same surface but as the space 22 is closed, the interaction of light with compounds and tissue occurs over a larger distance at space 21 than at space 22.
  • the closed space 22 forms a spacer.
  • a spacer can also be formed of a solid material transparent to the incident light.
  • a "spacer” is to be understood as a volume in which no interaction of light with compounds and tissue occurs.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Claims (11)

  1. Dispositif (1) destiné à être implanté sous la peau (2) d'une créature vivante, ce dispositif ayant des surfaces externes en matériau biocompatible et comprenant :
    - des moyens de détection (8) pour détecter la lumière,
    - des moyens de transmission pour transmettre un signal issu desdits moyens de détection à un dispositif externe, dans lequel
    lesdits moyens de détection (8) sont positionnés au niveau
    - d'un premier groupe d'une pluralité de surfaces sensiblement plates à un premier niveau et
    - d'un second groupe d'une pluralité de surfaces sensiblement plates à un second niveau,
    la disposition des premier et second groupes de surfaces à l'intérieur du dispositif est telle que la distance entre la peau (2) et lesdits moyens de détection (8), sur laquelle la lumière issue d'une source de lumière (4) interagit avec des composés et du tissu au niveau dudit premier groupe de surfaces, diffère de la distance entre la peau (2) et lesdits moyens de détection (8), sur laquelle la lumière issue d'une source de lumière interagit avec des composés et du tissu au niveau dudit second groupe de surfaces.
  2. Dispositif selon la revendication 1, dans lequel chaque surface de chaque groupe de surfaces forme un niveau commun, et dans lequel les niveaux communs ont un espacement prédéterminé l'un par rapport à l'autre pour assurer ladite différence de distance sur laquelle la lumière interagit avec des composés et du tissu.
  3. Dispositif selon la revendication 2, dans lequel ledit premier groupe de surfaces est formé à un niveau de base (9) du dispositif et ledit second groupe de surfaces est formé par des protubérances (10) entre ledit niveau de base et un niveau de dessus.
  4. Dispositif selon la revendication 1, comprenant en outre un séparateur (21, 22), recouvrant l'un desdits groupes de surfaces de telle sorte que les composés et le tissu ne peuvent remplir le volume du séparateur, le séparateur (21, 22) assurant la différence de distance sur laquelle la lumière interagit avec des composés et du tissu.
  5. Dispositif selon la revendication 3, dans lequel au moins une surface sensiblement plate, constituant un(e) troisième surface ou groupe de surfaces, est prévue et forme un niveau commun entre ledit niveau de base et ledit niveau de dessus.
  6. Dispositif selon l'une quelconque des revendications 1 à 5, dans lequel au moins une partie de l'une desdites surfaces est formée d'une membrane perméable.
  7. Dispositif selon la revendication 6, dans lequel ladite membrane est perméable au glucose.
  8. Procédé de détection optique du contenu d'un composé dans le corps d'une créature vivante, ce procédé comprenant :
    l'orientation d'une source de lumière (4) sur différentes surfaces d'un dispositif implanté contenant des moyens de détection, la distance, entre la peau (2) et lesdits moyens de détection (8), sur laquelle la lumière issue d'une source de lumière interagit avec des composés et du tissu au niveau d'une surface différant de la distance, entre la peau (2) et lesdits moyens de détection (8), sur laquelle la lumière issue d'une source de lumière interagit avec des composés et du tissu au niveau d'une autre surface ;
    l'obtention de signaux représentant la lumière au moyen desdits moyens de détection (8) ; et
    l'analyse des signaux détectés, cette analyse étant basée de préférence sur la différence entre les signaux détectés, pour obtenir une valeur du contenu d'un composé détecté.
  9. Procédé selon la revendication 8, dans lequel l'analyse est basée sur une moyenne des signaux.
  10. Procédé selon la revendication 8 ou la revendication 9, dans lequel le composé est du glucosc.
  11. Procédé selon la revendication 8, dans lequel le dispositif implanté (1) est conçu selon l'une quelconque des revendications 1 à 7.
EP02791814A 2001-12-17 2002-12-12 Procede et dispositif de suivi de la concentration d'un analyte par detection optique Expired - Lifetime EP1455641B1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DK200101904 2001-12-17
DKPA200101892 2001-12-17
DK200101892 2001-12-17
DKPA200101904 2001-12-17
DKPA200200224 2002-02-14
DK200200224 2002-02-14
PCT/EP2002/014141 WO2003051191A1 (fr) 2001-12-17 2002-12-12 Procede et dispositif de suivi de la concentration d'un analyte par detection optique

Publications (2)

Publication Number Publication Date
EP1455641A1 EP1455641A1 (fr) 2004-09-15
EP1455641B1 true EP1455641B1 (fr) 2008-09-03

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US (1) US7248906B2 (fr)
EP (1) EP1455641B1 (fr)
AT (1) ATE406835T1 (fr)
AU (1) AU2002358128A1 (fr)
DE (1) DE60228755D1 (fr)
WO (1) WO2003051191A1 (fr)

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ATE406835T1 (de) 2008-09-15
DE60228755D1 (de) 2008-10-16
US20050070770A1 (en) 2005-03-31
WO2003051191A1 (fr) 2003-06-26
AU2002358128A1 (en) 2003-06-30
EP1455641A1 (fr) 2004-09-15

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